Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

Gur­net Point Cap­i­tal-backed Au­re­gen Bio­Ther­a­peu­tics has tapped Am­gen vet Richard Davies to lead its rare dis­ease cell ther­a­py’s en­try in­to the clin­ic as CEO. Davies, a for­mer Hos­pi­ra chief com­mer­cial of­fi­cer who had his first chief ex­ec­u­tive ex­pe­ri­ence re­cent­ly at Bone­sup­port, will lead the dri­ve in trans­lat­ing the Gene­va-based biotech’s 3D bio­fab­ri­ca­tion tech­nolo­gies to new ther­a­peu­tics, start­ing from a pro­gram in rare con­gen­i­tal cran­io­fa­cial dis­or­ders.

→ Brick­ell Biotech has hired in­dus­try vet­er­an and Lil­ly $LLY Chief Mar­ket­ing Of­fi­cer Robert Brown to take the reins at the der­ma­tol­ogy com­pa­ny as it preps a late-stage tri­al eval­u­at­ing its drug, sof­piro­ni­um bro­mide, in pa­tients with ex­ces­sive un­der­arm sweat­ing in the first half of 2019. Brown, who has spent over three decades at Lil­ly, is set to re­place Brick­ell’s cur­rent CEO and co-founder Regi­nald Hardy on Jan­u­ary 1.

Bo Rode Hansen is step­ping up from a CSO po­si­tion to take the top job at Genevant. Un­like the rest of Vivek Ra­maswamy’s biotech fam­i­ly, the com­pa­ny is not in-li­cens­ing late-stage pro­grams, but build­ing a pipeline from scratch us­ing Ar­bu­tus’ RNA tech, with the aim of de­liv­er­ing more than five in-house and part­nered can­di­dates for clin­i­cal de­vel­op­ment by 2020. Hansen, the for­mer glob­al head of RNA at Roche with 50 dis­cov­ery pro­grams un­der his belt, will play a lead­ing role along­side a sea­soned ex­ec team.

→ A year af­ter Mary Szela left the helm of Nov­e­l­ion Ther­a­peu­tics $NVLN, the rare dis­ease biotech is shak­ing up its CEO of­fice again. Jef­frey Hack­man, the for­mer COO who’s been fill­ing in, has re­signed as in­ter­im CEO, pass­ing the re­spon­si­bil­i­ties to gen­er­al coun­sel Ben­jamin Harsh­barg­er. Hav­ing helped se­cure a re­cent loan fa­cil­i­ty, Harsh­barg­er is charged with the grand turn­around mis­sion by first fix­ing the cap­i­tal struc­ture.

→ Al­most a year af­ter step­ping down from Syn­er­gy Phar­ma­ceu­ti­cals — a com­pa­ny he found­ed and co-in­vent­ed the lead drug for — Gary Ja­cob has land­ed at a mi­cro­bio­me biotech in Aus­tralia. As CEO, Ja­cob is ex­pect­ed to chan­nel both his de­vel­op­ment, fi­nan­cial and com­mer­cial ex­per­tise in steer­ing Im­muron’s $IM­RN pipeline of oral­ly de­liv­ered poly­clon­al an­ti­bod­ies, which is led by a pro­gram for liv­er dis­eases.

→ Fol­low­ing a wide-rang­ing ca­reer fea­tur­ing stints at No­var­tis, L’Ore­al and SBM Man­age­ment Ser­vices, Stephan Jack­man has been ap­point­ed CEO of Alza­mend Neu­ro, a biotech de­vel­op­ing a cou­ple of Alzheimer’s drug can­di­dates out of the Uni­ver­si­ty of South Flori­da. Pri­or to the new role, Jack­man was fo­cused on ad­vanc­ing cures for mos­qui­to borne in­fec­tious dis­eases as COO of En­naid Ther­a­peu­tics.

→ New­ly pub­lic Ma­gen­ta Ther­a­peu­tics $MG­TA has scooped Ja­son Ryan from Foun­da­tion Med­i­cine to be its chief op­er­at­ing and fi­nan­cial of­fi­cer. The high fly­ing Cam­bridge start­up, which has a port­fo­lio fo­cused on bone mar­row trans­plant, can ben­e­fit from Ryan’s ex­pe­ri­ence in cap­i­tal cre­ation and al­lo­ca­tion as well as com­mer­cial plan­ning, says CEO Ja­son Gard­ner, as demon­strat­ed in his ef­forts with Foun­da­tion’s re­cent sale to Roche.  

→ Gothen­burg, Swe­den-based Iso­fol has hired Roger Tell — a bio­phar­ma vet who’s al­so run mul­ti­ple tri­als as a prin­ci­pal in­ves­ti­ga­tor — to run its clin­i­cal pro­gram as it ad­vances its lead prod­uct can­di­date in­to Phase III. Ar­foli­tixorin, de­vel­oped through a part­ner­ship with Mer­ck KGaA, is de­signed to boost the ef­fects of chemother­a­py main­ly in col­orec­tal can­cer. As CSO and SVP of clin­i­cal de­vel­op­ment, Tell will al­so over­see  sci­en­tif­ic re­search and tech­ni­cal op­er­a­tions.

→ With its Phase III pro­grams well un­der­way, Apel­lis Phar­ma­ceu­ti­cals $APLS has tapped Adam Townsend to plot a mar­ket­ing plan for APL-2 — its com­ple­ment C3 in­hibitor look­ing to ri­val Soliris in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — and al­so build a fran­chise in ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion. The new chief com­mer­cial joins from Bio­gen, where he helped lead the launch­es of Tec­fidera and Spin­raza.

→ Fol­low­ing an 11-year ca­reer run­ning clin­i­cal op­er­a­tions for mul­ti­ple units — in­clud­ing the oph­thalmic fran­chise — at No­var­tis, Fabio Baschiera is jump­ing to an oph­thal­mol­o­gy start­up backed by the phar­ma gi­ant. His new ti­tle at Oculis will be VP of clin­i­cal de­vel­op­ment. Al­so join­ing the Swiss biotech: Louie-Anne Gau­thi­er, who will now scout deals for Oculis’ eye drop al­ter­na­tives for in­jectable drugs as its VP of strate­gic mar­ket­ing, busi­ness de­vel­op­ment and li­cens­ing.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.